Breast Reconstruction and Body Map : Assessment by Functional MRI (REMASCO)

Centre Oscar Lambret

Status: Completed

Conditions: Breast Cancer

Treatments: Device: Functional MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT02553967

REMASCO-1503

Details and patient eligibility

About

Breast reconstruction is an integral part of the management of patients with breast cancer and treated by total mastectomy. The aim of breast reconstruction is to get a satisfying aesthetic and functional result (sensitivity) and that would enable the patient to appropriate the reconstructed breast. Patient satisfaction assessed subjectively by questionnaires would be better in autologous reconstructions than in reconstructions by prosthesis.

The aim of our trial is to use functional MRI (fMRI) as an objective evaluation tool to describe the brain functional changes of sensory projections after immediate or secondary breast reconstruction.

Full description

Patients responding criteria for selection and not objecting to participate in this trial will address a quality of life questionnaire at baseline. Then the study procedures differ depending on which group the patient belongs to.

Immediate breast reconstruction group : Six months after surgery (or six months after the implantation of the definitive prosthesis in case of use of a tissue expander), a postoperative fMRI will be performed and patients will be asked to complete a quality of life form and a satisfaction form.

Secondary breast reconstruction group :

• In the two months preceding the surgery, a preoperative fMRI will be performed.
• Six months after surgery (or six months after the implantation of the definitive prosthesis in case of use of a tissue expander), a postoperative fMRI will be performed and patients will be asked to complete a quality of life form and a satisfaction form.

Enrollment: 49 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient with an indication of unilateral total mastectomy with immediate breast reconstruction for initial breast cancer or recurrence, Or patient undergoing a unilateral secondary breast reconstruction
2. WHO performance status less than or equal to 2
3. Age ≥ 18 years
4. For patients of childbearing age, use of an effective contraceptive method for the duration of the study
5. Patient having been informed and having signed an informed consent form for the study.

Exclusion criteria

1. Patient undergoing a breast reconstruction by exclusive lipomodelling
2. Contraindication to MRI : claustrophobia, intra-orbital metallic fragment, pregnancy, cochlear implants, incompatible metallic foreign body such as certain pacemaker and mechanical valves
3. Patient with an indication of preoperative radiotherapy or adjuvant chemotherapy according to regional and/or national standards
4. History of brain surgery
5. History of contralateral breast surgery
6. History of prophylactic total mastectomy
7. Reconstruction techniques using a mixed procedure (autologous + prosthesis)
8. Patient on medication that may alter the BOLD signal in MRI
9. Pregnant or breastfeeding women
10. Patient under tutorship or guardianship

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Immediate breast reconstruction

Experimental group

Description:

* Total mastectomy + immediate reconstructive surgery * 6 months after surgery : Functional MRI and questionnaires

Treatment:

Device: Functional MRI

Secondary breast reconstruction

Experimental group

Description:

* Within 2 months before surgery : Functional MRI * Reconstructive surgery * 6 months after surgery : Functional MRI and questionnaires

Treatment:

Device: Functional MRI